Siemens Healthcare Diagnostics, Inc.
FDA 510(k) & PMA Approved Devices — 72 products
Total Devices72
Categories49
Latest FDA decision2026-08-10
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K192788 | ADVIA Centaur Cortisol (COR) | JFT | 2019-11-25 | View |
| 510(k) | K192777 | ADVIA Centaur CA 15-3 assay | MOI | 2019-11-22 | View |
| 510(k) | K192790 | Atellica IM Total hCG (ThCG) | DHA | 2019-10-30 | View |
| 510(k) | K191533 | ADVIA Centaur Testosterone II (TSTII), ADVIA Centaur SHBG | CDZ | 2019-08-28 | View |
| 510(k) | K191454 | Atellica CH Amylase_2 (AMY_2) | JFJ | 2019-07-30 | View |
| 510(k) | K191578 | ADVIA Centaur Zika test, ADVIA Centaur Zika Ab (100 tests), ADVIA Centaur Zika IgM (50 tests), ADVIA Centaur Zika Ab Quality Control, ADVIA Centaur Zika IgM Quality Control | QFO | 2019-07-17 | View |
| 510(k) | K190675 | Dimension EXL High-Sensitivity Troponin I (TNIH) Assay | MMI | 2019-05-17 | View |
| 510(k) | K182225 | Dimension Vista High-Sensitivity Troponin I (TNIH) Assay | MMI | 2019-03-04 | View |
| 510(k) | K181213 | ADVIA Centaur CMV IgG and ADVIA Centaur CMV IgG Quality Control | LFZ | 2018-07-30 | View |
| 510(k) | K171566 | Atellica IM High-Sensitivity Troponin I (TNIH) | MMI | 2018-07-19 | View |
| 510(k) | K181002 | Atellica IM BRAHMS Procalcitonin (PCT) | PMT | 2018-07-16 | View |
| 510(k) | K173909 | Dimension Hemoglobin A1c Assay | PDJ | 2018-07-13 | View |
| 510(k) | K171274 | ADVIA Centaur High-Sensitivity Troponin I (TNIH) | MMI | 2018-07-12 | View |
| 510(k) | K181082 | ADVIA Chemistry Cystatin C_2 Assay (CYSC_2) | NDY | 2018-05-25 | View |
| 510(k) | K172201 | Atellica IM Folate Assay | CGN | 2018-04-12 | View |
| 510(k) | K172322 | Atellica IM Total hCG (ThCG) | JHI | 2018-03-29 | View |
| 510(k) | K171771 | ADVIA Chemistry Enzymatic Hemoglobin A1c (A1c_E) Assay | PDJ | 2017-12-04 | View |
| 510(k) | K170293 | Emit II Plus Cocaine Metabolite Assay | DIO | 2017-10-25 | View |
| 510(k) | K172910 | Emit II Plus Oxycodone Assay | DJG | 2017-10-18 | View |
| 510(k) | K171642 | Atellica IM Ferritin Assay | DBF | 2017-08-31 | View |
No matching devices.
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